Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase I Study of Extended Low Dose Temozolomide (SCH 52365, Temodar (R)) and Carmustine (BCNU) in the Treatment of Malignant Gliomas After Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005637
• Other study ID #: CDR0000067793
• Secondary ID: MSKCC-99114NCI-G
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2000
• Last updated: April 2, 2013
• Start date: December 1999
• Est. completion date: December 2009

Study information

• Verified date: March 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.

Description:

OBJECTIVES:

• Determine the safety and efficacy of extended low-dose temozolomide when combined with carmustine after radiotherapy in patients with malignant glioma.

• Determine the maximum tolerated dose of this combination in this patient population.

• Determine time to progression as measured from baseline gadolinium-enhanced magnetic resonance imaging in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of temozolomide.

Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours beginning within 72 hours after starting temozolomide. Courses repeat every 8 weeks for up to 1 year in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant glioma

• Glioblastoma

• Gliosarcoma

• High-grade glioma

• Anaplastic astrocytoma

• Anaplastic mixed oligoastrocytoma

• Anaplastic oligodendroglioma

• Anaplastic ependymoma

• Must have completed radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• SGOT/SGPT less than 3 times ULN

• Alkaline phosphatase less than 2 times ULN

Renal:

• BUN less than 1.5 times ULN

• Creatinine less than 1.5 times ULN

Pulmonary:

• Pulmonary function test with diffusion greater than 50 OR

• Clearance by the pulmonary service

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No AIDS-related illness

• No nonmalignant systemic disease that would preclude study

• No acute infection requiring IV antibiotics

• No psychiatric condition that would preclude study compliance

• No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)

• No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 2 weeks since prior radiotherapy

Surgery:

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• carmustine

• temozolomide

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,